Medical errors, infection-control breaches and the use of adulterated and misbranded medical devices

Table 1 Several of the infection-control breaches identified at three Veterans Affairs Medical Centers in Murfreesboro (TN), Augusta (GA) and Miami (FL)

Breach	Details of breach	Guidelines, manufacturers’ instructions	Infection risk
Improper reprocessing of irrigation tubing used during colonoscopy (Murfreesboro, TN)[1,2]	For as many as 5 yr, the VAMC in Murfreesboro (TN) had been using the Olympus MAJ-855 auxiliary water tube that was: (1) fitted with an improper “two-way” connector; and (2) reprocessed once at the end of the day, not after each patient procedure, as required[2]. Further, the short “irrigation tube” that connects the MAJ-855 tube to a flushing pump was not discarded at the end of the day, also as required[2,8]	According to its manufacturer: (1) the MAJ-855 tube is to be used only with the “one-way” valve with which it is manufactured and shipped (the removal of this valve and its replacement with the two-way connector used by the Olympus MH-974 “washing tube” is contraindicated); (2) the MAJ-855 tube is to be reprocessed after each procedure; and (3) the short irrigation tube is to be discarded at the end of each day[2,9]	Use of the MAJ-855 tube fitted with the MH-974’s two-way connector (instead of the correct one-way valve) can result in: the auxiliary water tube’s malfunction, its contamination due to the “back-flow” of potentially infectious debris from the patient’s colon, and patient-to-patient disease transmission[2]. Further, failure to clean and high-level disinfect (or sterilize) the MAJ-855 tube after each patient procedure, or to discard the short irrigation tube at the end of each day, also poses an increased risk of infection[2,9]
Improper reprocessing of colonoscopes (Miami, FL)[1,2]	For as many as 5 yr, the VAMC in Miami (FL): (1) failed to reprocess the MAJ-855 tube after each procedure, instead merely flushing or rinsing it with (sterile) water; (2) often connected the MAJ-855 tube to the colonoscope while the procedure was already in progress; and (3) did not discard the short irrigation tube (that connects the MAJ-855 tube to a flushing pump) at the end of the day[2]. In addition, “debris” had been identified in the auxiliary water channel of “reprocessed” colonoscopes[2]	According to its manufacturer: (1) the MAJ-855 tube is to be cleaned and high-level disinfected (or sterilized) after each procedure; (2) the MAJ-855 tube is to be connected to the colonoscope, with the auxiliary water system primed, prior to the procedure; and (3) the short irrigation tube is to be discarded at the end of the day[2,9]. The use of an endoscope whose channels are soiled with patient debris is contraindicated[1,2,63,74-77]	Indeed, (1) The failure to clean and high-level disinfect the colonoscope, including its auxiliary water channel, or to discard the short irrigation tube at the end of each day; or, (2) the practice of neither cleaning and high-level disinfecting (or sterilizing) the MAJ-855 tube after each patient procedure nor connecting the MAJ-855 tube to the colonoscope, with the auxiliary water system primed, prior to the procedure, poses an increased risk of disease transmission[2]
Improper cleaning and high-level disinfection of flexible laryngoscopes (Augusta, GA)[1,2]	For almost a year, the VAMC in Augusta (GA) had been improperly reprocessing flexible laryngoscopes after each procedure, namely, by merely wiping them down with a disposable “sanitizing” cloth[2]	Guidelines and manufacturers’ instructions require cleaning and high-level disinfection (or sterilization) of flexible endoscopes and other semi-critical items after each use[49,61,75,78]. The use of an improperly cleaned or disinfected flexible laryngoscope is contraindicated[1-3,75,78]	The improper cleaning and/or high-level disinfection of flexible endoscopes have been causally associated with disease transmission[61,74-80]

The Veterans Health Administration (VHA) concluded that each of these infection-control breaches posed an increased risk of infection[2]. Consequently, in accordance with the VHA’s relevant directives[14], patients were notified of these breaches and of their potential for infection. Several recommendations to prevent infections associated with each of these breaches are provided in Table 6. VAMC: Veterans Affairs Medical Center.

Table 2 Several of the infection-control breaches identified within the VA Caribbean Healthcare System, in Puerto Rico

Breach	Details of breach	Guidelines, manufacturers’ instructions	FDA regulations	Infection risk
Improper high-level disinfection of transvaginal ultrasound transducers[1,3,12]	For approximately 2 yr, the VAMC (in San Juan) and an outpatient clinic (in Mayaguez) did not high-level disinfect transvaginal ultrasound transducers after each use[3]. Instead, staff sprayed these instruments with an ineffective disinfectant (and then, at least at this clinic in Mayaguez, covered them with two latex sheaths before use). Whether these transducers were properly cleaned prior to being sprayed is unclear	Transvaginal ultrasound transducers are semi-critical devices for which high-level disinfection (or sterilization) is recommended after each use[75,81], whether or not these transducers are covered with a protective sheath[1,75,82]		Failure to clean and/or to high-level disinfect these semi-critical devices poses an increased risk of patient infection[75,81]. Further, improperly reprocessed transvaginal ultrasound transducers, even when covered with a protective sheath during the procedure, may pose an increased risk of transmission of infectious agents, including HPV[75,82]
Failure to leak-test colonoscopes[1,3,12]	Colonoscopes used in this VAMC’s operating room were not leak-tested for (at least) 9 mo[3]	Leak testing of the colonoscope is required after each procedure, just prior to cleaning[3,79,83]. This test detects leaks that can permit fluids to invade and damage the endoscope’s internal structures[3]. Manufacturers’ instructions contraindicate the use of a colonoscope (or flexible laryngoscope) that fails this crucial test[83]		Leak testing of the colonoscope is also critical to infection control[3]. Reports causally associate use of a torn or damaged flexible endoscope, with a leak, to disease transmission[3,75,79]
Failure to leak-test flexible laryngoscopes; and the use of a damaged laryngoscope[1,3,12]	Having not leak-tested these instruments for 9 mo, this VAMC (namely, its radiotherapy department) routinely used a damaged flexible laryngoscope, with a leak. Similarly, an outpatient clinic (in Ponce) did not leak-test its flexible laryngoscopes for 3 yr[3]	Leak testing of the laryngoscope is required after each procedure, just prior to cleaning[3,78]. Manufacturers’ instructions contraindicate the use of a laryngoscope that is damaged and/or fails the leak test[3,83]		Both the use of damaged flexible endoscopes and the failure to leak test them have been causally associated with disease transmission[79,80]
Improper cleaning (and high-level disinfection) of flexible laryngoscopes[1,3,12]	For possibly as many as 9 mo, this VAMC (namely, its radiotherapy department) was not properly cleaning a flexible laryngoscope after each procedure using a detergent[3]. Instead, it was rinsed with running water (followed by drying with a clean gauze pad). Further, for 3 yr an outpatient clinic (in Ponce) was not properly cleaning (nor leak testing; see above) its flexible laryngoscope after each use, and this clinic, too, may not have been properly high-level disinfecting the laryngoscope[3]	Guidelines and manufacturers’ instructions require the cleaning (using a detergent) and high-level disinfection of flexible endoscopes after each use[2,3,63,74-78]. The use of an improperly cleaned or high-level disinfected laryngoscope is contraindicated[2,3,75]		Because the laryngoscope was not properly cleaned, this VAOIG report acknowledges that “adequate (high-level) disinfection cannot be ensured”[3]. The improper cleaning and/or high-level disinfection of flexible endoscopes have been causally associated with disease transmission[64,74,76,77,79]
Use of a misbranded flexible laryngoscope[1,3,12]	For possibly as many as 3 yr, an outpatient clinic (in Ponce) used a misbranded flexible laryngoscope[3]		A misbranded device lacks the necessary clearance to be legally marketed in the US[17,43,56]. The use of a misbranded (or adulterated) device is expressly prohibited by the Food, Drug and Cosmetic Act, unless the “unapproved” device has received, for example, an approved “investigational device exemption” (or, IDE), which, among other considerations, requires for its use informed patient consent[17,56]	The safety and effectiveness of a misbranded medical device cannot be assured, and its use could pose an increased risk of patient harm including infection[41,42,45]

The Veterans Health Administration (VHA) concluded that each of these five listed breaches posed a “negligible” risk of infection[1,3,10]. Consequently, patients were not notified of the potential for their exposure to infectious agents, including HIV and other blood-borne pathogens[12]. Several recommendations to prevent infections associated with each of these breaches are provided in Table 6. VAMC: Veterans Affairs Medical Center.

Table 3 Assessed risk of infection associated with nine different confirmed infection-control breaches, the number of patients notified of the breach, and the reference discussing the breach

Assessed risk of infection1	No. of patients notified	Ref.
Negligible2	No patients notified	[1,3,12]
Extremely low	1812	[84]
Small but not zero3	> 10 000	[2,6]
Extremely low	> 500	[85]
Extremely remote	9000	[86]
Minimal to non-existent	360	[87]
Extremely low risk	38	[88]
No increased risk	> 3500	[4,5]
Very low risk	6800	[7,89]

¹Although this table’s nine risk assessments are seemingly without significant clinical differences, the actions associated with each assessment were, at times, notably dissimilar. Whereas breaches assessed to have a “negligible” infection risk did not result in patient notification (Table 3’s first row), other breaches assessed either to have similar infection risks, including “extremely low” and “extremely remote” infection risks, nevertheless resulted in patient notification;

²Some researchers who have studied these breaches have instead concluded that each posed an increased risk of infection warranting the notification of affected patients[1,10,12]. Among other considerations, including to be consistent with the VHA’s policies and procedures[14,15], patient notification is important to transparency and quality improvement;

³These breaches were also assessed to have a “low but significant risk”[2] of infection and a risk of infection that is “substantially less than 1 in 10 000”[2]. The table’s sign “>” denotes “more than”.

Table 4 A timeline of significant events associated with the STERIS System 1 and System 1E

Year	Events
1988	The Food and Drug Administration (FDA) grants the STERIS System 1 (“SS1”) and its accompanying Steris 20 sterilant a 510(k) clearance (reference No. K875280)[19]
1992-1998	Several articles questioning the safety and effectiveness of the SS1 are published[21,29,33,38-40]
1996	The FDA grants a 510(k) clearance for a biological indicator (BI) to be used exclusively with the SS1[25]
1999	A hospital in New York City (NY) links patient injury to the SS1[34,35]
1999	The CDC writes a report that links the SS1 to patient injury[34]
February 2000	The safety and effectiveness of the SS1 is questioned in the newspaper Investors Business Daily[25]
October 2000	Another article questioning the safety of the SS1 is published[36]
April 2001	The FDA raises doubts about the “sterility” of the SS1’s filtered rinse water and, therefore, about the SS1’s effectiveness[32]
2002-2004	Two articles questioning the labeling claims, effectiveness and safety of devices (like the SS1) labeled to achieve liquid chemical sterilization are published[23,31,36,37]
2003, 2004	A hospital in Pittsburgh (PA) links patient injuries to the SS1’s rinse water and “defective” water filters[21,90,91]
2003	An ex-employee of STERIS asserts that the SS1 “poses a public health risk”[21,90]
Circa 2004	The federal government investigates whether the SS1 may have been “adulterated”[21,90,91]
December, 2004	The safety and effectiveness of the SS1 is questioned in the newspaper The Wall Street Journal[21]
April, 2008	The safety of the SS1, namely, the validity of its labeling claim that the SS1’s filtered rinse water is “sterile,” is again questioned[22]
May, 2008	On May 15, 2008, the FDA issues a warning letter concluding that the SS1 is adulterated and misbranded pursuant to the Food, Drug and Cosmetic (FD&C) Act[43]. The FDA states in this letter that changes made to the SS1 by its manufacturer could significantly affect the device’s safety and effectiveness
January, 2009	Steris “discontinues” marketing of the SS1 and its Steris 20 sterilant[44]
January, 2009	Steris submits a 510(k) application to the FDA requesting to market this censured and “updated” model of the SS1 known as the STERIS System 1E[44]
July-August, 2009	An article about the SS1 concludes that reusable medical instruments including rigid endoscopes whose labeling lists the (censured) SS1 as a reprocessing method may themselves be misbranded[16]
December 3, 2009	The FDA notifies healthcare facilities that the SS1 has been without a legal approval or clearance (as required for its marketing and sale) since 1988. Facilities are provided a period of 3-6 mo to transition to a legally marketed alternative[41,42,45]
January 5, 2010	While acknowledging that the SS1 is an “unapproved” device that “violates US federal law,” a Canadian health agency writes that it has “no objection” to this device’s continued sale and use[58]
February 2, 2010	The FDA extends for 18 mo (through August 2, 2011) the time period for healthcare providers to stop using the unapproved SS1 and transition to a legally marketed alternative[46]
February 22, 2010	The FDA writes a letter stating that reusable medical instruments including rigid endoscopes listing in their labeling the (censured) SS1 as a reprocessing method are themselves be misbranded[15,48]
April 5, 2010	The FDA grants the “updated” SS1, known as the STERIS System 1E, or SS1E, a 510(k) clearance. Unlike the SS1’s clearance in 1988, however, the SS1E is cleared without a BI or a “sterile water” claim[20]
April 6, 2010	The FDA clarifies the SS1E’s 510(k) clearance, stating that this device’s filtered rinse water “is not sterile” and, therefore, its “final processed devices (or instruments) are not sterile”[51]
April 9, 2010	The FDA again writes about the SS1E’s clearance, adding that “because the rinse water is not sterile, devices processed using liquid chemical sterilization cannot be assured to be sterile”[50]
April-July, 2010	On April 20, 2010, the FDA obtains a Consent Decree of Permanent Injunction, requiring its manufacturer to stop selling the unapproved SS1[52]. Pursuant to this Injunction, each healthcare provider continuing to use the SS1 (and to receive service, parts, consumables, accessories, including purchase and use of the Steris 20 sterilant) are required to complete and return to the SS1’s manufacturer a signed Certificate of Medical Necessity (CN) by July 2, 2010[53,54]
March, 2011	The FDA extends the use of the unapproved SS1 for 6 more months, until February 2, 2012[55]
December, 2011	The FDA again extends the use of the unapproved SS1 (and both the sale and use of its Steris 20 sterilant) for 6 more months, until August 2, 2012[47]. This time, however, the FDA requires healthcare providers continuing to use the SS1 (and to receive service, parts, consumables, accessories, including purchase and use of the Steris 20 sterilant) to sign, complete, and comply with a Certificate of Transition, which is to be returned to the SS1’s manufacturer by February 2, 2012[47]
February 2, 2012	Healthcare providers who have not completed and returned to its manufacturer a signed Certificate of Transition by February 2, 2012, will be prohibited from using the unapproved SS1 and from purchasing its accompanying Steris 20 sterilant[47,52-54]
March 30, 2012	The FDA grants a 510(k) clearance for a spore test strip (i.e., a BI) to be used exclusively with the SS1E
August 2, 2012	According to the FDA, healthcare providers (who had returned a signed Certificate of Transition to the SS1’s manufacturer by February 2, 2012) can no longer use the unapproved SS1 after August 2, 2012[47]

Table 5 Recommendations that are provided for healthcare facilities, federal agencies, medical device manufacturers, and healthcare organizations and administrations, to minimize the risk of injury to patients and of legal exposure to healthcare facilities

To healthcare facilities:

Review a previously published set of instructions for reprocessing the Olympus MAJ-855 auxiliary water tube, along with the colonoscope’s auxiliary water channel[10]. Also, review Table 6

Before using an adulterated or misbranded device, or a censured medical device subject to a consent decree and/or CN: (1) consider whether describing it as investigational subject to an approved IDE, the oversight by an IRB and informed patient consent is warranted; and (2) ensure that its use does not contravene the healthcare facility’s policies and procedures (or other documents, including its insurance policies[59])

Ensure that the certification of a censured device’s continued use pursuant to a signed CN (or CT) is lawful and based on sound medical considerations and patient safety

To maintain a consistent standard of patient care, quality, and transparency, consider patient disclosure of a medical error to be the norm, no matter whether the error is an infection-control breach associated with a low risk of infection (Table 3)[1,5,12]

The use of a wet flexible endoscope or surgical instrument to treat patients is not recommended. Prior to their use (and storage), wet, processed flexible endoscopes, such as those processed by the SS1 (or SS1E), may be dried using 70% alcohol followed by forced air

Consider periodically monitoring the microbial quality of the water used to rinse flexible (and rigid) endoscopes following their high-level disinfection or liquid chemical sterilization. Contaminated rinse water will yield contaminated, processed instruments. Failure to monitor the rinse water microbiologically precludes assurances that it does not contain potentially pathogenic microorganisms

Review the history of the SS1’s use, regulation, and discontinuation (Table 4). Also, review the risk assessments provided in Tables 1-3

Review all infection-control product’s labeling claims. Question any processor’s labeling that “guarantees” sterilization (or high-level disinfection)

To regulatory agencies:

Continued attention to the scientifically-sound, active regulation of medical devices with infection-control applications is appreciated. One important aspect of this oversight is the frequent and/or detailed auditing of medical device manufacturers, to ensure, among other considerations, the proper control and documentation of any changes to a medical device’s labeling and design. Also recommended are more frequent and thorough audits by international standard organizations that certify the quality of manufacturers

Continued efforts to ensure that the wording of 510(k) clearances describing a device’s intended use is clear and consistent are encouraged. Cleared labeling claims that detail what the device does achieve, rather than what it does not achieve (e.g., the SS1E’s FDA-cleared liquid chemical sterilization claim), are important to quality and to reducing the risk of confusion, user error, and patient harms

Consider eliminating the oxymoronic and anomalous claim of liquid chemical sterilization and replacing it with a more scientific and consistent claim (e.g., enhanced, ultra, or rapidly sporicidal high-level disinfection)

Also recommended are: (1) the enhanced attention of consent decrees, CNs and CTs to transparency, and patient safety; (2) the definitive clarification by the FDA whether the continued use of an unapproved or otherwise censured device requires an approved IDE; and (3) improved efforts to ensure that the patient’s rights, safety and welfare are protected whenever an unapproved or otherwise censured device is used

To manufacturers:

Adopt more rigorous quality and regulatory standards that prevent the design, manufacture, sale and marketing of potentially unsafe, mislabeled, ineffective, or unapproved medical devices [e.g., those without a 510(k) clearance or PMA]. Do not change or modify the designs (including the labeling and intended uses) of medical devices (e.g., the re-formulation of a high-level disinfectant’s labeling and chemical ingredients) without adequate documentation and control (per the FDA’s Quality System Regulation). Submit to the FDA for its review and clearance substantively modified devices prior to their marketing and sale. Whenever in doubt, conclude that a design change requires a new 510(k) submission

Use caution before including in a reusable surgical instrument’s instructions for use (IFUs) a reprocessing device (e.g., the SS1), that is adulterated, misbranded, or lacks adequate design control, documentation and/or data validating its labeling claims, safety, and compatibility with the surgical instrument’s materials. Otherwise, the FDA may consider the surgical instrument to be itself misbranded

To healthcare organizations:

Consider a more proactive role in the oversight of the safety and effectiveness of infection-control products and of the validity of their labeling claims

Consider publishing guidance to advise a medical facility evaluating whether the continued use of a censured medical device subject to a CN (e.g., the SS1) is legally and medically sound; warrants an approved IDE including informed patient consent; could adversely impact a healthcare facility’s accreditation, certification, or licensing; and requires any corrective or preventative actions or changes in clinical practice

To the VHA:

Notification of patients affected by the infection-control breaches confirmed within the Caribbean in 2009 (Table 2) is recommended[1,3,12], to ensure compliance and consistency with the VHA’s relevant directives and policies vis-a-vis patient notification[14]; a consistent standard of patient care; and a commitment to transparency and quality. In general, consider patient notification to be the norm[5,14]

To patients:

While formal recommendations for patients are not, per se, the focus of this article, some guidance is provided

If an infection is contracted (or other type of patient harm is encountered) during or following a medical procedure, among other considerations:

Verify that the healthcare facility did not use (without the patient’s knowledge) a medical device that had been censured, adulterated, misbranded, described as investigational, or subject to a signed CN and/or CT (e.g., the SS1)

Investigate whether, at the time the patient received medical care or treatment, any known or undisclosed infection-control breaches, lapses, or medical errors were identified by the healthcare facility

Consider contacting the healthcare facility prior to a procedure and ask for the facility to certify its relative risk of infections and other adverse events, compared to other facilities. Ensure that this risk is based on internal data that have been independently validated for accuracy and completeness

Patients potentially affected by one or more of the breaches confirmed within the Caribbean and listed in Table 2 might consider contacting the VHA and requesting being tested to ensure they were not infected with a transmissible disease due to any of these confirmed breaches

These patients may also consider asking the VHA for evidence-based justification for having not notified them of any of these breaches listed in Table 2. The medical literature suggests that these breaches may have posed an increased risk of infection

Consider having a blood test taken before the procedure to demonstrate a negative blood-borne pathogen result. A positive result promptly after the procedure might implicate the procedure as the infection’s cause

Table 6 Several recommendations to prevent patient infections associated with the breaches described in Tables 1 and 2

Olympus MAJ-855 auxiliary water tube:

Clean and high-level disinfect (or steam sterilize) the MAJ-855 auxiliary water tube (in accordance with its manufacturer’s instructions)[9]. Recommendations for reprocessing this MAJ-855 tube and the colonoscope’s auxiliary water tube have been previously published[10]

Improper reprocessing, or the misuse, of the MAJ-855 tube may pose an increased risk of infection warranting patient notification[2]

Colonoscope:

After each clinical case, clean and high-level disinfect (at a minimum) the colonoscope (and all other types of GI endoscopes)[64]. Refer to the colonoscope’s operator’s manual for detailed reprocessing instructions[83]

In addition to its other channels and surfaces, including the suction and air/water valves, reprocess the auxiliary water channel regardless of whether this channel was used or flushed with water during the clinical case[76,77]. Do not use the GI endoscope if assurances that this channel (or any other surface) was properly reprocessed cannot be provided

Soil dripping from a “reprocessed” colonoscope may indicate improper cleaning of the auxiliary water channel. Do not use a visibly soiled or improperly reprocessed GI endoscope rather, reprocess it again before its reuse

Improper reprocessing of the colonoscope and its auxiliary water channel may pose an increased risk of infection warranting patient notification[2]

Prior to its reprocessing, visually inspect (for damage) and leak-test the colonoscope, in accordance with its manufacturer’s instructions. Do not use a colonoscope that has not been leak-tested, has a leak and fails this test, is torn, and/or is otherwise damaged. Return the damaged colonoscope to its manufacturer, in accordance with its operator’s manual

Flexible laryngoscope:

After each clinical case, clean and high-level disinfect (at a minimum) the flexible laryngoscope, including, if featured, its suction channel, suction valve, and biopsy inlet or port[2,78]

A unique set of step-by-step instructions for reprocessing laryngoscopes is provided in reference 78, to which the reader is referred

Prior to its reprocessing, visually inspect (for damage) and leak-test the flexible laryngoscope, in accordance with its manufacturer’s instructions. Do not use a flexible laryngoscope that has not been leak-tested, has a leak and fails this test, is torn, and/or is otherwise damaged. Instead, return the flexible laryngoscope to its manufacturer, in accordance with its operator’s manual

Improper reprocessing of the flexible laryngoscope-for example, failing to use a detergent to clean it; or “cleaning” and “disinfecting” its surfaces by wiping them with a sanitizing cloth or a gauze soaked with a disinfectant, such as 70% alcohol or a quaternary ammonium product-may pose an increased risk of infection warranting patient notification[1,2,6]

Service and maintain the flexible laryngoscope, like all types of flexible endoscopes, including colonoscopes, as recommended by its manufacturer[80]

Transvaginal ultrasound transducer (or probe):

After each clinical case, clean and high-level disinfect (at a minimum) the transvaginal ultrasound transducer regardless of whether this reusable probe was covered with one or two protective sheaths[75,82]. Refer to this transducer’s reprocessing manual for more detailed instructions

Improper reprocessing of this transducer-for example, “cleaning and disinfecting” its surfaces by spraying them with a disinfectant; wiping them with a disposable sanitizing cloth; or using running tap water (without detergent)-may pose an increased risk of infection warranting patient notification[1,12,81]